By: David Krubsack, PhD
Good documentation requires a good document control system. Regulated medical products need to follow FDA or similar requirements for auditable documentation. This often is so restrictive with such intensive oversight that basic corporate technical knowledge is never captured.
A simple solution can be a second documentation system. To differentiate it from the more restrictive production documentation, it can go by various names including research, engineering, or preproduction documentation. For this article, I’ll call it “preproduction”.
A couple requirements for the preproduction document control system are 1) each document has an alphanumeric “number” and revision, and 2) once the controlled document is released, no one can change it other than to update it by releasing a new document with the same number and the consecutive revision. It is presumed that any electronic file may be attached to the document when it is released. The only oversight necessary is to ensure these two requirements are met.
This preproduction system could be implemented completely independent from the production system. However, there are advantages of making them similar or even integrated. For example, the production documents can use revisions A, B, C, etc. while the preproduction documents use 1, 2, 3, etc.
With an integrated approach, there can be less overhead and confusion with differences between the two systems. For example, the document types can be the same, removing confusion as to which type is in which system. An entire documentation structure can be prototyped in the preproduction numeric (1, 2, 3) revision and released to alpha (A, B, C) as each document is completed and approved. In such an integrated system, numeric revisions can be updated to alpha revisions, but not vice versa.
Personnel who will be releasing documents into the preproduction system might not be familiar with all the requirements and procedures of the production document control system. Preproduction documentation allows them to still release critical information without having to learn the rest of the production system. It also provides them with many example document types as a starting point and they can indirectly learn the production system.
Until now, this article has primarily focused on controlling documents. Software and data also need to be controlled for similar reasons. A simple way to control software and data is to attach them as electronic files to a controlled document. Just as document control systems have features that facilitate document management, a separate software version control (SVC) system can have features that facilitate software management. Data can alternatively be controlled by releasing them as electronic files into the software version control system. In some cases, a separate data version control (DVC) system with specialized features may be used. Machine learning models are another kind of data that should be controlled.
The most optimal implementation of a preproduction and production document, software, and/or data control system will depend on the company objectives and the tools already in place. In addition to consulting regulatory advisors, input should be obtained from any personnel who will be gathering, managing, or using the resulting data.
Keep the following table in mind when creating a control system. Where applicable, overlap can reduce the size of the table. In any case, every controlled element (documents, software, data) needs to be able to be referenced by its assigned alphanumeric “number” (e.g. DOC-123-456) and its version (e.g. 1, 2, 3, A, B, C).
|Preproduction Documents||Production Documents|
|Preproduction Software||Production Software|
|Preproduction Data||Production Data|
Table 1. Controllable elements and level of oversight.
For any controlled element, having a preproduction control system in addition to the production control system will encourage the capture of valuable corporate knowledge without the restrictions of a regulated and fully auditable control system.